Diabetes Drugs: US FDA Advice On Premarketing Safety Database Raises Industry Concerns
A draft guidance recommendation for 4,000 patient-years of exposure in Phase III, including at least 1,200 patients with comorbid conditions, is too proscriptive, unnecessarily large and lacks justification, biopharma industry comments say.
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US FDA withdraws controversial 2008 guidance that required sponsors to exclude threshold levels of cardiovascular risk before and after approval; new draft guidelines emphasize duration of exposure and breadth of safety evaluations in more diverse Phase III trial population, consistent with advisory committee recommendations.
Premarketing trials that enroll more diverse patient populations and include targeted CV endpoint collection over longer periods of time could be sufficient to allow new type 2 diabetes drugs to reach market without need for a dedicated safety study, advisory committee members say, urging FDA to move away from current two-step approach to cardiovascular risk assessments.
US FDA received 110 designation requests in July, a high mark that reflects the 60 days needed to review such requests ahead of the 30 September statutory expiration; agency is allowing email submission of RPD and orphan drug designation requests during the COVID-19 pandemic and expects to roll out an online portal for orphan designation requests later this year.